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Trial Outcomes & Findings for The Efficacy of Phosphatidylserine-Omega3 in Elderly Subjects With Memory Impairment (NCT NCT00736034)

NCT ID: NCT00736034

Last Updated: 2010-03-30

Results Overview

The computerized neuropsychological assessment software consists of seven separate tasks: symbol spotting, pattern identification, pattern recall, digit-symbol substitution, digits span forward, digits span backward and delayed pattern recall. Based on the results obtained in the single tasks, eight cognitive composite scores are calculated including focused attention, sustained attention, memory recognition \& recall, visuospatial learning, spatial short term memory, executive functions and mental flexibility.The total score range is from 0 to 100 points(0 is worse, 100 is best).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

18 participants

Primary outcome timeframe

baseline, 15 weeks

Results posted on

2010-03-30

Participant Flow

Participants were recruited through advertisements in senior citizens' homes, hospitals, and newspapers.

Participant milestones

Participant milestones
Measure
PS-Omega3
Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals
Overall Study
STARTED
18
Overall Study
COMPLETED
16
Overall Study
NOT COMPLETED
2

Reasons for withdrawal

Reasons for withdrawal
Measure
PS-Omega3
Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals
Overall Study
Adverse Event
2

Baseline Characteristics

The Efficacy of Phosphatidylserine-Omega3 in Elderly Subjects With Memory Impairment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
PS-Omega3
n=18 Participants
Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals
Age Continuous
75.29 years
STANDARD_DEVIATION 7.09 • n=93 Participants
Sex: Female, Male
Female
9 Participants
n=93 Participants
Sex: Female, Male
Male
9 Participants
n=93 Participants
Region of Enrollment
Israel
18 participants
n=93 Participants

PRIMARY outcome

Timeframe: baseline, 15 weeks

The computerized neuropsychological assessment software consists of seven separate tasks: symbol spotting, pattern identification, pattern recall, digit-symbol substitution, digits span forward, digits span backward and delayed pattern recall. Based on the results obtained in the single tasks, eight cognitive composite scores are calculated including focused attention, sustained attention, memory recognition \& recall, visuospatial learning, spatial short term memory, executive functions and mental flexibility.The total score range is from 0 to 100 points(0 is worse, 100 is best).

Outcome measures

Outcome measures
Measure
PS-Omega3
n=18 Participants
Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals
Change From Baseline in Neuropsychological Computerized Test
Focused Attention
3.16 Points on a scale
Standard Deviation 12.39
Change From Baseline in Neuropsychological Computerized Test
Sustained Attention
-2.38 Points on a scale
Standard Deviation 11.09
Change From Baseline in Neuropsychological Computerized Test
Memory - Recognition
1.88 Points on a scale
Standard Deviation 9.86
Change From Baseline in Neuropsychological Computerized Test
Memory - Recall
4.50 Points on a scale
Standard Deviation 12.14
Change From Baseline in Neuropsychological Computerized Test
VisuoSpatial Learning
8.83 Points on a scale
Standard Deviation 24.31
Change From Baseline in Neuropsychological Computerized Test
Spatial Short Term Memory
13.16 Points on a scale
Standard Deviation 29.88
Change From Baseline in Neuropsychological Computerized Test
Executive Functions
-2.88 Points on a scale
Standard Deviation 19.72
Change From Baseline in Neuropsychological Computerized Test
Mental Flexibility
-3.88 Points on a scale
Standard Deviation 20.21

SECONDARY outcome

Timeframe: 15 weeks

The Clinical Global Impression of Change (CGI-C)scale is designed to record the clinician's global impression of change. Global improvement score ranges from 1 = "Very much improved", through 4 = "No change", to 7 = "Very much worse". Participants who experienced an improvement (scores 1, 2 or 3) were classified as improved over the treatment period.

Outcome measures

Outcome data not reported

Adverse Events

PS-Omega3

Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
PS-Omega3
n=18 participants at risk
Treatment will consist of capsules containing 100 mg phosphatidylserine-Omega3. Dosage: 1 capsule X 3 times daily, with meals
Gastrointestinal disorders
gastrointestinal disorders
5.6%
1/18 • Number of events 1
General disorders
Hepatitis
5.6%
1/18 • Number of events 1

Additional Information

Dr. V. Vakhapova

Sourazky Tel-Aviv Medical Center

Phone: 972-3-6973698

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place